Cleared Traditional

NPB-190 PULSE OXIMETER (NPB-190) (K971946) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K971946 · Nellcor Puritan Bennett, Inc. · Anesthesiology device
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Aug 1997
Decision
90d
Days
Class 2
Risk

K971946 is an FDA 510(k) clearance for the NPB-190 PULSE OXIMETER (NPB-190). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nellcor Puritan Bennett, Inc. (Lenexa, US). The FDA issued a Cleared decision on August 25, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nellcor Puritan Bennett, Inc. devices

Submission Details

510(k) Number K971946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1997
Decision Date August 25, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 176
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K971946.
CRICKET 2000 RECORDING PULSE OXIMETER
K972829 · Respironics, Inc. · Oct 1997
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)
K970061 · Datascope Corp. · Sep 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K973222 · Siemens Medical Solutions USA, Inc. · Sep 1997
VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)
K964978 · Quinton, Inc. · May 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
K970368 · Siemens Medical Solutions USA, Inc. · May 1997
OHMEDA 3800 PULSE OXIMETER
K962127 · Ohmeda Medical · Oct 1996